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采用不同聚合物直接压片制备佐米曲普坦舌下片的配方研究:体外和体内评价。

Formulation of zolmitriptan sublingual tablets prepared by direct compression with different polymers: in vitro and in vivo evaluation.

机构信息

Gulhane Military Medical Academy, Department of Pharmaceutical Sciences, Ankara, Turkey.

出版信息

Eur J Pharm Biopharm. 2011 Aug;78(3):499-505. doi: 10.1016/j.ejpb.2011.02.014. Epub 2011 Feb 23.

Abstract

First-pass metabolism can be overcome by sublingual drug delivery, and quick drug entry into the systemic circulation can be obtained. In certain diseases such as migraine therapy, taking fast pharmacological response is an important criteria. In this study, zolmitriptan sublingual tablets were prepared by direct compression method using different mucoadhesive polymers such as hydroxypropyl methyl cellulose, chitosan and sodium carboxy methyl cellulose at a concentration range of 0.5-5% to reduce flushing action of saliva and provide enough time for drug to be absorbed. Tablets were evaluated for the physical properties, and optimum formulations were chosen for in vivo studies to carry on sheep model. The tablets disintegrated rapidly, and dissolution tests revealed that zolmitriptan was dissolved from the formulation within the compendial limits. This especially showed us that the concentration range of polymers is in acceptable limit. It was also concluded that microcrystalline cellulose, spray-dried lactose and sodium starch glycolate are the appropriate excipient and formulated in good proportions. In vivo studies indicated that formulation containing 5% chitosan has the maximum C(max) and AUC and minimum t(max) values (p<0.05). As a result, sublingual tablet administration of zolmitriptan formulated with appropriate excipients and especially with chitosan seems promising alternative to traditional routes.

摘要

首过代谢可以通过舌下给药来克服,并且可以快速将药物进入体循环。在某些疾病如偏头痛的治疗中,快速的药理反应是一个重要的标准。在这项研究中,采用羟丙甲纤维素、壳聚糖和羧甲基纤维素钠等不同的粘膜粘附聚合物,通过直接压片法制备佐米曲普坦舌下片,浓度范围为 0.5-5%,以减少唾液的冲洗作用,并为药物吸收提供足够的时间。对片剂进行了物理性质的评价,并选择了最佳的配方进行体内研究,以进行绵羊模型实验。结果表明,这些片剂迅速崩解,溶出度试验表明佐米曲普坦在配方中的溶解符合规定。这表明聚合物的浓度范围是可以接受的。此外,还得出结论,微晶纤维素、喷雾干燥乳糖和交联羧甲基纤维素钠是合适的赋形剂,并以良好的比例进行了配方。体内研究表明,含有 5%壳聚糖的配方具有最大的 C(max)和 AUC 值以及最小的 t(max)值(p<0.05)。因此,佐米曲普坦的舌下片给药方式,采用适当的赋形剂,特别是壳聚糖,似乎是传统途径的有前途的替代方法。

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